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Trial registered on ANZCTR


Registration number
ACTRN12612000723886
Ethics application status
Approved
Date submitted
15/06/2011
Date registered
6/07/2012
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of an interactive decision aid for prostate cancer screening
Scientific title
A randomised controlled trial of an online interactive decision aid applied to prostate cancer screening for men aged 40 to 69 years, assessing decision quality
Secondary ID [1] 262349 0
None
Universal Trial Number (UTN)
U1111-1121-9610
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
PSA testing for prostate cancer. 268049 0
Condition category
Condition code
Public Health 268189 268189 0 0
Health promotion/education
Public Health 268190 268190 0 0
Epidemiology
Cancer 268191 268191 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We have developed an online decision aid (‘My Prostate Cancer Screening Annalisa’) for men aged 40 to 69 years. The aid summarises the evidence for the benefits, potential harms and other factors associated with screening and elicits individual participant’s preferences for each factor associated with the decision to screen (the benefits, potential harms and other factors).
Responses to these questions are used to generate a personalised decision aid for the user.
There are two arms of the trial:
Control arm: Users are asked to indicate how important 5 attributes of prostate cancer screening (benefits and potential harms) are to them; these were pre-installed by researchers based on literature (RCT data) and a pilot study (i.e. the attributes are fixed). This arm is referred to as My Prostate Cancer Screening Annalisa: Fixed Attributes.
Intervention arm: Users are asked to choose the attributes they would like to include in their decision aid, from a total of 10 attributes. That is, users pick their own attributes. This arm is called My Prostate Cancer Screening Annalisa: You Choose. The control decision aid takes about 15 minutes to complete. The intervention decision aid takes about 18 minutes to complete.
Intervention code [1] 266738 0
Early detection / Screening
Intervention code [2] 285219 0
Prevention
Comparator / control treatment
The comparator is the ‘fixed attribute’ interactive decision aid.
Control group
Active

Outcomes
Primary outcome [1] 266931 0
Primary outcome: Decision quality as measured by "MyDecisionQuality" an eight point scale that encompasses dimensions of making a high quality health decision.
Timepoint [1] 266931 0
Baseline (after completion of interactive decision aid).
Secondary outcome [1] 276648 0
Secondary Outcome 1: The proportion of the intervention and control group who indicate they are more likely to visit their GP to discuss PSA testing after interacting with either the 'Pick Your Own' (PYO) or Fixed Attribute (control group) decision aids. (The PYO version is where participants choose, from a list of 10 attributes, the ones they think are important to them). This will be assessed in the online questionnaire by asking participants to indicate how likely they are to see their GP about PSA testing before and after they use the appropriate decision aid.
Timepoint [1] 276648 0
After interaction with the decision aid.

Eligibility
Key inclusion criteria
40-69 year old men living in Australia who have access to the internet and a reasonable command of the English language.
Minimum age
40 Years
Maximum age
69 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
No access to the internet, insufficient English, younger than 40 years or older than 69 years.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Global Market Insite, Inc. (GMI) will recruit 1,398 participants from their panel of 130,000 Australians. Eligible participants who agree to be in the study will be randomly allocated to one of the two arms of the study. This is done centrally by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
For each of the three age strata simple randomisation is performed using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1398
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,ACT,QLD,SA,WA,NT,TAS

Funding & Sponsors
Funding source category [1] 267228 0
Government body
Name [1] 267228 0
National Health and Medical Research Council (NHMRC)
Country [1] 267228 0
Australia
Primary sponsor type
Individual
Name
Professor Glenn Salkeld
Address
A27 - Edward Ford Building
The University of Sydney
NSW 2006 Australia
Country
Australia
Secondary sponsor category [1] 266460 0
None
Name [1] 266460 0
Address [1] 266460 0
Country [1] 266460 0
Other collaborator category [1] 252049 0
Individual
Name [1] 252049 0
Dr Michelle Cunich
Address [1] 252049 0
Sydney Medical School
Edward Ford Building (A27)
University of Sydney, NSW 2006
Country [1] 252049 0
Australia
Other collaborator category [2] 252050 0
Individual
Name [2] 252050 0
Professor Emeritus Jack Dowie
Address [2] 252050 0
Tavistock Place, London School of Hygiene and Tropical Medicine
London
15-17 Tavistock Place
WC1H 9SH UK
Country [2] 252050 0
United Kingdom
Other collaborator category [3] 252051 0
Individual
Name [3] 252051 0
Dr Kirsten Howard
Address [3] 252051 0
Sydney Medical School
Edward Ford Building (A27)
University of Sydney, NSW 2006
Country [3] 252051 0
Australia
Other collaborator category [4] 252052 0
Individual
Name [4] 252052 0
Associate Professor Manish Patel
Address [4] 252052 0
Westmead Hospital
PO Box 533
Wentworthville, NSW
2145
Country [4] 252052 0
Australia
Other collaborator category [5] 252053 0
Individual
Name [5] 252053 0
Professor Graham Mann
Address [5] 252053 0
Westmead Millennium Institute for Medical Research
PO Box 533
Wentworthville, NSW
2145
Country [5] 252053 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269218 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 269218 0
Ethics committee country [1] 269218 0
Australia
Date submitted for ethics approval [1] 269218 0
31/03/2011
Approval date [1] 269218 0
02/06/2011
Ethics approval number [1] 269218 0
05-2011/13712

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32722 0
Address 32722 0
Country 32722 0
Phone 32722 0
Fax 32722 0
Email 32722 0
Contact person for public queries
Name 15969 0
Professor Glenn Salkeld
Address 15969 0
Sydney Medical School
Edward Ford Building (A27)
University of Sydney, NSW 2006
Country 15969 0
Australia
Phone 15969 0
+61 2 9036 9262
Fax 15969 0
+61 2 9036 9019
Email 15969 0
[email protected]
Contact person for scientific queries
Name 6897 0
Professor Glenn Salkeld
Address 6897 0
Sydney Medical School
Edward Ford Building (A27)
University of Sydney, NSW 2006
Country 6897 0
Australia
Phone 6897 0
+61 2 9036 9262
Fax 6897 0
+61 2 9036 9019
Email 6897 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe role of personalised choice in decision support: A randomized controlled trial of an online decision aid for prostate cancer screening.2016https://dx.doi.org/10.1371/journal.pone.0152999
N.B. These documents automatically identified may not have been verified by the study sponsor.